UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053655 |
|---|---|
| Receipt number | R000060551 |
| Scientific Title | Trial to Evaluate the Performance Enhancement Effects During Exercise by the Consumption of a Test Food Product |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2024/10/08 11:38:19 |
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Basic information
Public title
Trial to Evaluate the Performance Enhancement Effects During Exercise by the Consumption of a Test Food Product
Acronym
Trial to Evaluate the Performance Enhancement Effects During Exercise by the Consumption of a Test Food Product
Scientific Title
Trial to Evaluate the Performance Enhancement Effects During Exercise by the Consumption of a Test Food Product
Scientific Title:Acronym
Trial to Evaluate the Performance Enhancement Effects During Exercise by the Consumption of a Test Food Product
Region
| Japan |
Condition
Condition
Male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of single and continuous 4-week consumption of the test food containing peptide materials on maximum anaerobic power, muscle strength (grip strength, knee extension force), vasodilation, post-exercise muscle pump-up (thigh circumference), post-exercise fatigue, and muscle soreness in adults over 20 years of age with a habit of strength training.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POWER MAX
Key secondary outcomes
Physical condition questionnaire (muscle soreness, feeling of fatigue, muscle pump), Physical condition VAS (Visual Analogue Scale) questionnaire (muscle soreness, feeling of fatigue, muscle pump), Flow-Mediated Dilation (FMD), Grip strength, Knee extension strength, Thigh circumference, Body weight, Body Mass Index (BMI), Physiological tests, Hematological tests, Blood biochemistry tests, General urine analysis, Body fat percentage, Physical condition questionnaire (sensation and motivation after training)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the low-dose test food containing peptide materials (one packet containing three tablets) once daily for 4 weeks.
Interventions/Control_2
Consumption of the high-dose test food containing peptide materials (one packet containing three tablets) once daily for 4 weeks.
Interventions/Control_3
Consumption of the placebo food (one packet containing three tablets) once daily for 4 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1. Males aged 20 to below 50 years at the time of consent acquisition.
2. Subjects who have been performing leg strength training exercises aimed at muscle hypertrophy at least once every two weeks for more than three months (including leg extensions, leg curls, dumbbell squats, deadlifts, and bodyweight squats).
3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who regularly consume Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health supplements (including pre-workout supplements) that contain ingredients listed in the prohibited food list.
2. Subjects who plan to start consuming Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health supplements (including pre-workout supplements) that contain ingredients listed in the restricted food list.
3. Subjects who are participating the other clinical trials. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical trials.
4. Subjects with excessive alcohol intake.
5. Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
6. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
7. Subjects with allergies to medications and/or food.
8. Subjects who easily experience diarrhea from dairy products (including those aware of lactose intolerance).
9. Subjects who donated blood or component (200 mL) within the last 1 months.
10. Subjects who donated blood (400 mL) within the last 3 months.
11. Subjects who being collected in total of blood (1200 mL) within the last 12 months and in this study.
12. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
List of Prohibited Food Ingredients
Citrulline
Arginine
Agmatine
Low molecular weight lychee polyphenols
Cocoa flavanols
5,7-Dimethoxyflavone derived from black ginger
Astaxanthin
Monomeric and dimeric flavanols derived from lychee and tea
Imidazole dipeptides
List of Restricted Food Ingredients
Essential amino acids with 40% leucine composition
Branched-Chain Amino Acids (BCAA)
Citric Acid
beta-Hydroxy beta-Methylbutyrate (HMB)
Milk-derived Sphingomyelin
Creatine Monohydrate
beta-Alanine
5-Aminolevulinic Acid Phosphate
Maslinic Acid
Xanthophylls derived from red bell pepper
Corosolic Acid derived from Banaba leaves
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060551
